MAUDE Adverse Event Report: PENUMBRA, INC. RUBY COIL; HCG, KRD

Catalog Number	RBY2C0312
Medical Device Problem Codes	Physical Resistance/Sticking (4012); Premature Separation (4045)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/03/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Results: the pet lock was intact on the proximal end of the pusher assembly.The stretch resistant wire (sr wire) was fractured and the proximal constraint sphere was within the pusher assembly distal detachment tip (ddt).The embolization coil was not returned for evaluation.The pull wire was advanced distal to the ddt.Conclusions: evaluation of the returned ruby coil pusher assembly revealed that the sr wire was fractured, and the pull wire was advanced distal to the ddt.If the ruby coil is forcefully advanced against resistance, the pull wire may advance through its alignment feature and distal to the ddt.Subsequently retracting the ruby coil against resistance may result in the sr wire fracturing.The non-penumbra microcatheter used during the procedure was not returned for evaluation; therefore, the root cause of the resistance could not be determined.Penumbra coils are visually inspected during in-process inspection and during quality inspection after manufacturing.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the right inferior phrenic artery using ruby coils.During the procedure, the physician experienced resistance while advancing the third ruby coil through a non-penumbra microcatheter.The physician then decided to retract the ruby coil to flush the microcatheter.However, upon removal of the ruby coil pusher assembly, it was noticed that the ruby coil had unintentionally detached inside the microcatheter.Therefore, the microcatheter containing the detached ruby coil was removed.The physician then tried to flush the detached ruby coil out of the microcatheter but it was unsuccessful.The procedure was completed using new ruby coils and a new non-penumbra microcatheter.There was no report of an adverse effect to the patient.The patient then expired three days post-procedure from other complications.

• Brand Name: RUBY COIL
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 9403203
• Report Number: 3005168196-2019-02222
• Device Sequence Number: 19576436
• Product Code: HCG
• UDI-Device Identifier: 00814548012827
• UDI-Public: 00814548012827
• Combination Product (Y/N): Y
• Initial Reporter Country: SN
• PMA/510(K) Number: K120330
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/05/2019
• Report Date (Section F): 01/01/2005

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: RBY2C0312
• Device Lot Number: F91431
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/18/2019
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/05/2019
• Initial Report FDA Received Date: 12/03/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 79 YR
• Date Report Sent to FDA: 01/01/2005